ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase
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ClinicalTrials.gov Identifier: NCT00819351 |
Recruitment Status :
Completed
First Posted : January 9, 2009
Last Update Posted : April 21, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Lymphoblastic Leukemia | Drug: PEG Asparaginase at six weeks interval Drug: PEG Asparaginase at two weeks interval | Phase 3 |
20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.
The specific and primary objectives of the randomised study is:
To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 650 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | NOPHO Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults(18.0-45.0 Years) With Acute Lymphoblastic Leukemia. Intermittent Versus Continuous PEG-asparaginase for Asparagine Depletion |
Actual Study Start Date : | January 1, 2009 |
Actual Primary Completion Date : | March 2, 2016 |
Actual Study Completion Date : | March 2, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: PEG-asparaginase 6 weeks intervals
PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (from week 13 after diagnosis to week 33). All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms. |
Drug: PEG Asparaginase at six weeks interval
PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy)
Other Name: Oncaspar (PEG-Asparaginase) |
Active Comparator: PEG-Asparaginase 2 weeks intervals
PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (from week 13 after diagnosis to week 33). All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms. |
Drug: PEG Asparaginase at two weeks interval
PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (until the patient has received 33 weeks of therapy)
Other Name: Oncaspar (PEG-Asparaginase) |
- Event Free Survival [ Time Frame: 6 years ]
- Secondary Outcome Measures are toxicity (special focus on thrombosis, pancreatitis, and allergic reactions), the formation of silent antibodies, and the influence of antibody production on the EFS. [ Time Frame: 6 years ]

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Ages Eligible for Study: | 1 Year to 45 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Childhood ALL
- All mandatory biological data are available6
- Written informed consent has been obtained
Exclusion Criteria:
- Bilineage ALL
- Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
- ALL predisposition syndromes
- Previous cancer
- Off protocol administration of additional chemotherapy during induction therapy
- Sexually active females not using contraception
- No allergic reactions to PEG Asparaginase

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819351
Denmark | |
Department of Pediatrics, Rigshospitalet | |
Copenhagen, Denmark, 2100 | |
Finland | |
Helsinki University Hospital | |
Helsinki, Finland | |
Iceland | |
University Hospital Reykjavik, Iceland | |
Reykjavik, Iceland | |
Norway | |
Trondheim University Hospital | |
Trondheim, Norway | |
Sweden | |
Department of Pediatrics, Drottning Sylvias Pediatric Hospital | |
Gothenburg, Sweden | |
NOPHO nordic organisation for pediatric onology | |
Stockholm, Sweden |
Study Chair: | Kjeld Schmiegelow, M.D. | Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kjeld Schmiegelow, Professor, Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00819351 |
Other Study ID Numbers: |
NOPHO ALL2008 PEG Asparaginase |
First Posted: | January 9, 2009 Key Record Dates |
Last Update Posted: | April 21, 2017 |
Last Verified: | April 2017 |
acute lymphoblastic leukemia child PEG-Asparaginase |
EFS efficacy childhood acute lymphoblastic leukemia |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Asparaginase Pegaspargase Antineoplastic Agents |